Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Recruiting

• Conditions: Cardiogenic Shock; Muscle Atrophy; Skeletal Muscle Atrophy; Heart Failure
• Interventions: Diagnostic Test: BodyMetrix Body Composition Ultrasound

• Registration Number: NCT06253104
• Lead Sponsor: Tufts Medical Center

Brief Summary

This study aims to determine, via skeletal muscle ultrasound (US), the extent, timing and relationship between skeletal muscle mass loss and outcomes after orthotropic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation amongst patients with cardiogenic shock. Advanced therapies such as OHT and VADs in the heart failure (HF) population may promote skeletal muscle mass and subsequent quality of life, but there is a lack of literature assessing muscle mass changes in HF patients before and after advanced therapies using US imaging. Therefore this observational study will provide further insight into the 1) changes in lean body mass during critical illness and 2) the feasibility of using bedside US to assess lean body mass in the inpatient setting.

Detailed Description

The investigators will be recruiting subjects with advanced cardiomyopathy in cardiogenic shock in the inpatient setting. This is an observational study to better understand changes in lean body mass during critical illness through a quick, safe, and non-invasive method. This study will also validate the use of the BodyMetrix BX 2000 Pro ultrasound machine for the assessment of body composition, particularly muscle wasting, in the cardiogenic shock population.

The ultrasound device received 501(k) designation from the FDA in 2009 for measurement of localized fat and muscle thickness. Baseline US muscle thickness assessments will occur at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (discharge or death). Each measurement session will take about 20-30 minutes.The investigators will take measurements at two sites: the lateral thigh and bicep (participant's dominant side). Clear ultrasound gel will be applied to the skin and the ultrasound probe placed against the skin, and the muscle thickness measurement made five times at each position.

The US images are read after a study visit completion, with measurements taken at pre-specified anatomic landmarks to obtain the muscle thickness, which is averaged accross the duplicate measurements. The primary endpoints are: Percentage change in skeletal muscle thickness from admission to nadir; Percentage change in skeletal muscle thickness after advanced therapies; and the Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes.

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-12
• Study Start: 2024-02-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Over 18 years of age
2. Ejection fraction <40%
3. Cardiogenic shock defined by clinical criteria (including any of: lactate >2.5 mmol/L, systolic blood pressure <90 mmHg, acute kidney or liver injury, or cardiac index <2.1 on hemodynamic monitoring) plus the clinical requirement for at least one pressor, inotrope, or temporary mechanical circulatory support device (MCSD)

Exclusion Criteria

1. History of LVAD or other durable ventricular assist device
2. An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke
3. Chronic enteric and parenteral nutrition support patients

Intubation or prior history of heart transplantation are not exclusion criteria if the inclusion criteria are otherwise met.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Cohort	BodyMetrix Body Composition Ultrasound	All enrolled participants with no randomization group allocations

Primary Outcome Measures

Name	Time	Method
Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes	Images obtained at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (discharge or death)	Evaluate the relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes. We hypothesize that a greater negative percent change in muscle thickness from admission to the nadir thickness value will be associated with higher inhospital mortality, and for those who receive an LVAD/HT a longer post-operative length of stay and greater probably of discharge to a rehabilitation facility as opposed to home.
Percentage change in skeletal muscle thickness from admission to nadir of muscle thickness	Images obtained at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (until discharge or death)	Quantify the percentage change in skeletal muscle thickness from admission to nadir of muscle thickness and describe the time course of muscle loss. We hypothesize that all patients will experience a decrease in skeletal muscle thickness in the days-to-weeks after admission, as indicated by change in skeletal muscle thickness on ultrasound, and anticipate the magnitude of this muscle thickness change to be in the range of -5%. This aim will be investigated in both patients who ultimately receive the HT or LVAD advanced therapies, and also those who do not.
Percentage change in skeletal muscle thickness after advanced therapies	Images obtained at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (until discharge or death)	Quantify the percentage change in skeletal muscle thickness achieved early after advanced therapies (LVAD/HT). We hypothesize that hospitalized patients with advanced heart failure will experience a minor muscle recovery during the hospital stay following advanced therapy surgeries, but not a recovery in the range of +5% which would likely require a 3-month follow-up period.

Secondary Outcome Measures

Name	Time	Method
Discharge to a rehabilitation facility versus home	Conclusion of index Hospitalization	Discharge destination at conclusion of index hospitalization
Geriatric nutritional risk index (GNRI)	Once at baseline	Evaluating the association between malnutrition risk as assessed by geriatric nutritional risk index (GNRI) on admission and change in skeletal muscle thickness from admission to nadir.
Inhospital mortality	Index Hospitalization	Occurence of mortality during index hospitalization
Upper extremity versus lower extremity US muscle thickness decreases	Images obtained at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (discharge or death)	Determine if an upper extremity or lower extremity US muscle site location for percentage change is most strongly associated with mortality and with GNRI on admission.
Post-LVAD/HT length of stay	Index Hospitalization	Days from LVAD/HT surgery until discharge from hospital or death

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States